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Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

NCT06003387 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-17

No results posted yet for this study

Summary

The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.

Conditions

  • Hemophilia B

Interventions

GENETIC

CSL222 (AAV5-hFIXco-Padua)

Administered as a single IV infusion.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2028-10-04
Completion
2032-04-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hong Kong
  • Israel
  • Mexico
  • Saudi Arabia
  • Singapore
  • South Africa
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003387 on ClinicalTrials.gov